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Metatarsophalangeal Arthrodesis of the Hallux

Metatarsophalangeal Arthrodesis of the Hallux : Observational Study Evaluating the Efficacy and Tolerance of Synthetic Methods Using Dorsal Plate and Large-diameter Screws

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05691075
Acronym
ARTHRODESE
Enrollment
3
Registered
2023-01-19
Start date
2023-03-15
Completion date
2023-07-16
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Deformity

Brief summary

The purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation.

Detailed description

The main objective of the study is to describe the rate of bone fusion obtained with the different types of osteosynthesis material: dorsal plate, large-diameter compression screw. Patients will be divided into two groups: * patient undergoing arthrodesis of the hallux with a large diameter screw (group A) * patient undergoing arthrodesis of the hallux by plate (group B) This is a prospective, cross-sectional, open, comparative, non-randomized, non-interventional, monocentric study on two methods of synthesis (large-diameter plate or screw) of hallux metatarsophalangeal arthrodesis. Patients will be managed in accordance with current practice, the choice of surgical strategy (percutaneous / open) being left to the discretion of the investigators.

Interventions

PROCEDUREArthrodesis of the metatarsophalangeal joint

Isolated surgery of the first ray of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach

Sponsors

Euraxi Pharma
CollaboratorINDUSTRY
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach; * Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw; * Patient able to understand information related to the study and complete quality of life questionnaires; * Patient accepting study follow-up visits; * Patient having been informed and agreeing to participate in the study.

Exclusion criteria

* Pregnant or breastfeeding women; * Patient undergoing lateral ray surgery; * Patient undergoing revision arthrodesis; * Patient with a loss of bone substance requiring a graft; * Patient suffering from chronic inflammatory disease; * Patient treated with long-term immunosuppressive or corticosteroid treatments; * Patient under guardianship or curatorship, or under a regime of deprivation of liberty.

Design outcomes

Primary

MeasureTime frameDescription
Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw)4 monthsRate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation, obtained with different types of osteosynthesis material: dorsal plate and large-diameter compressive screw

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026